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(MEDIHEALTH) in Improving Medication Adherence

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(MEDIHEALTH) in Improving Medication Adherence Ting et al. Trials (2018) 19:310 https://doi.org/10.1186/s13063-018-2649-9 STUDYPROTOCOL Open Access Effectiveness and sustainability of a structured group-based educational program (MEDIHEALTH) in improving medication adherence among Malay patients with underlying type 2 diabetes mellitus in Sarawak State of Malaysia: study protocol of a randomized controlled trial Chuo Yew Ting1, Shahren Ahmad Zaidi Adruce1*, Mohamed Azmi Hassali2, Hiram Ting3, Chien Joo Lim4, Rachel Sing-Kiat Ting5, Abu Hassan Alshaari Abd Jabar6, Nor Anizah Osman7, Izzul Syazwan Shuib8, Shing Chyi Loo8, Sui Theng Sim8, Su Ee Lim7 and Donald E. Morisky9 Abstract Background: Amidst the high disease burden, non-adherence to medications among patients with type 2 diabetes mellitus (T2DM) has been reported to be common and devastating. Sarawak Pharmaceutical Services Division has formulated a pharmacist-led, multiple-theoretical-grounding, culturally sensitive and structured group-based program, namely “Know Your Medicine – Take if for Health” (MEDIHEALTH), to improve medication adherence among Malay patients with T2DM. However, to date, little is known about the effectiveness and sustainability of the Program. Methods/design: This is a prospective, parallel-design, two-treatment-group randomized controlled trial to evaluate the effectiveness and sustainability of MEDIHEALTH in improving medication adherence. Malay patients who have underlying T2DM, who obtain medication therapy at Petra Jaya Health Clinic and Kota Samarahan Health Clinic, and who have a moderate to low adherence level (8-item Morisky Medication Adherence Scale, Malaysian specific, score <6) were randomly assigned to the treatment group (MEDIHEALTH) or the control group. The primary outcome of this study is medication adherence level at baseline and 1, 3, 6 and 12 months post-intervention. The secondary outcomes are attitude, subjective norms, perceived behavioural control, intention and knowledge related to medication adherence measured at baseline and 1, 6 and 12 months post-intervention. The effectiveness and sustainability of the Program will be triangulated by findings from semi-structured interviews with five selected participants conducted 1 month after the intervention and in-depth interviews with two main facilitators and two managerial officers in charge of the Program 12 months after the intervention. Statistical analyses of quantitative data were conducted using SPSS version 22 and Stata version 14. Thematic analysis for qualitative data were conducted with the assistance of ATLAS.ti 8. (Continued on next page) * Correspondence: [email protected]; [email protected] 1Institute of Borneo Studies, Universiti Malaysia Sarawak, Kota Samarahan, Sarawak, Malaysia Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Ting et al. Trials (2018) 19:310 Page 2 of 13 (Continued from previous page) Discussion: This study provides evidence on the effectiveness and sustainability of a structured group-based educational program that employs multiple theoretical grounding and a culturally sensitive approach in promoting medication adherence among Malays with underlying T2DM. Both the quantitative and qualitative findings of this study could assist in the future development of the Program. Trial registration: National Medical Research Register, NMRR-17-925-35875 (IIR). Registered on 19 May 2017. ClinicalTrials.gov, NCT03228706. Registered on 25 July 2017. Keywords: Culturally sensitive, Type 2 diabetes mellitus, Medication adherence, Malay patients, Group-based educational program, Randomized controlled trial Background significantly associated with better glycaemic control, Diabetes is an epidemic chronic disease caused either by less hospital visits and admissions, and lower medical costs. the failure of the pancreas in producing sufficient insulin On the other hand, a lower adherence rate was significantly or by the failure of the body cells in utilizing the insulin associated with poor medication tolerance, frequency of produced by the pancreas effectively [1]. The majority medication intake (more than two times a day), having (95%) of patients with diabetes have type 2 diabetes concomitant depression and negative belief about the mellitus (T2DM), which is more common in adults than medications. Consequently, patients who poorly adhere to in children [1, 2]. A national health and morbidity medications take more medications owing to poor gly- survey (NHMS) carried out by the Ministry of Health, caemic control and the development of micro- and macro- Malaysia (MOH), in 2015 revealed that 17.5% (95% Con- vascular complications [11]. Furthermore, the condition fidence interval 16.6, 18.3) of Malaysians were found to further worsens their adherence owing to more complex have diabetes [3]. In comparison with the results of the medications and more side effects experienced [7]. This first NHMS and the second NHMS conducted in 1986 inevitably increases the financial burden and wastage to and 1996, respectively, the recent findings again showed health services [12]. Hence, breaking the vicious cycle that there is a steady increase in the prevalence of dia- should be an urgent priority for all stakeholders. betes among Malaysians [4]. Besides, the national survey In Malaysia, the Pharmaceutical Services Division (PSD) found that there is a significant difference between differ- of the MOH launched in 2007 a campaign called “Know ent ethnic groups. Indians were found to have the highest Your Medicine” (KYM) to promote the quality use of prevalence of diabetes (22.1%, 95 CI 19.2-25.3), followed medicines [13]. The campaign utilizes mass media, social by the Malays (14.6%, 95 CI 13.8-15.5), the Chinese (12. media and a group-based educational program (GBEP) to 0%, 95 CI 10.7-13.5) and last the other indigenous groups deliver the message to the Malaysian public. The messages (10.7%, 95 CI 8.8-13.0). Even though Indians were found conveyed include information on their medication man- to have a greater percentage of T2DM than Malays, agement, such as why, how and when to take medicines, Malays have a higher total number of T2DM patients reporting adverse drug events, awareness on the rational owing to their bigger population size in Malaysia than use of medicines and medications that need special precau- Indians, which is the third largest ethnic group in tions. In particular, assuring and improving medication Malaysia [5]. adherence among patients is one of the important mes- Amidst the high disease burden, non-adherence to med- sages conveyed through the campaign. Moreover, the PSD ications among patients with T2DM has been reported to of Sarawak State Health Department further expanded the be common and devastating [6]. It has been estimated that scope of the GBEP by formulating a 3-h pharmacist-led more than 50% patients fail to achieve recommended culturally sensitive structured GBEP in promoting medica- glycaemic goals due to non-adherence to diabetic medica- tion adherence among T2DM patients [14]. The official tions [7, 8]. There is no exception for Malaysia as a re- name of the structured GBEP is “Know Your Medicine – cent national survey revealed that 73.1% of Malaysians Take it for Health” (MEDIHEALTH). Notably, MEDI- who are on medication did not adhere to the medica- HEALTH is a culturally sensitive and culturally appropriate tions prescribed [9]. program that is tailor-made to suit the cultural differences A recent systematic review [10] summarized that the of the major ethnicities in the State, including Iban, factors that contribute to poor adherence among T2DM Bidayuh, Malay and Chinese. In addition, MEDIHEALTH patients are age, ethnicity, health beliefs, medication cost, was specifically designed to complement the individual ap- insulin use, health literacy, medication cost, co-pays, med- proach in improving medication adherence among T2DM ical insurance coverage and primary non-adherence. Fur- patients called Diabetes Medication Therapy Adherence thermore,ontheonehand,agreateradherenceratewas Clinic (DMTAC) initiated by the PSD, MOH [15]. Previous Ting et al. Trials (2018) 19:310 Page 3 of 13 literature supports the employment of a structured GBEP attitude towards the behaviour, perceived subjective so- such as MEDIHEALTH because it has numerous irreplace- cial norms towards the behaviour and perceived behav- able benefits, including (1) validation, (2) normalization of ioural control towards the behaviour and is mediated by experience, (3) reduction of isolation, (4) sense of belong- the intention to act. Attitude towards the behaviour is ing and (5) enhanced self-esteem [16]. The design and how one evaluates the advantages or disadvantages of content of MEDIHEALTH will be further elaborated in the performing a behaviour. Subjective social norm is the “Methods/design” section. social expectations of a behaviour perceived by an indi- While the previous literature has
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